This trial is testing whether injecting skin cells from the palm or sole can thicken the skin layer at the site of an amputation below the knee, in order to improve healing.
- Stem Cells
1 Primary · 1 Secondary · Reporting Duration: 12 months
2 Treatment Groups
Autologous skin fibroblasts
1 of 2
1 of 2
50 Total Participants · 2 Treatment Groups
Primary Treatment: Autologous Skin Fibroblasts · Has Placebo Group · Phase 2
Who is running the clinical trial?
Age 18 - 65 · All Participants · 7 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Tsai, Jerry, Mary Rostom, and Luis A. Garza. 2022. “Understanding and Harnessing Epithelial‒mesenchymal Interactions in the Development of Palmoplantar Identity”. Journal of Investigative Dermatology. Elsevier BV. doi:10.1016/j.jid.2021.06.016.
- Tsai J, Rostom M, Garza LA. Understanding and Harnessing Epithelial-Mesenchymal Interactions in the Development of Palmoplantar Identity. J Invest Dermatol. 2022 Feb;142(2):282-284. doi: 10.1016/j.jid.2021.06.016. Epub 2021 Aug 6.
- 2019. "Autologous Volar Fibroblast Injection Into the Stump Site of Amputees". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03947450.
Frequently Asked Questions
Is this trial enrolling participants currently?
"According to the clinicaltrials.gov data, this experiment is still seeking participants and has been open since September 5th 2019, with its last revision on June 8th 2022." - Anonymous Online Contributor
Has the FDA provided clearance for Autologous Skin Fibroblasts?
"As this is a Phase 2 trial, the safety of Autologous Skin Fibroblasts has been provisionally evaluated at a score of two due to limited evidence on efficacy." - Anonymous Online Contributor
Are participants who are of an advanced age being enrolled in this research?
"This clinical trial outlines that patients aged 18 to 65 are eligible for inclusion. For those younger than 18 and older than 65, there exists 3 other trials tailored towards their age ranges." - Anonymous Online Contributor
Am I eligible to partake in this experiment?
"This clinical trial is enrolling 50 individuals, aged 18 and 65 who have had amputations. To qualify for the research study patients must also fulfill these requirements: demonstrate a negative pregnancy test at screening, be male or female between 18-65 years old with below-knee amputation; use a prosthetic device possess 3 months of experience or undergone osteo-integration of a prosthetic one month prior to entry into the trial; agree not to become pregnant/breastfeed during their participation and 1 month after completion; adhere to all scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other related" - Anonymous Online Contributor
How many individuals are partaking in this experiment?
"Affirmative. The records on clinicaltrials.gov demonstrate that this medical trial, which was originally published on September 5th 2019, is actively recruiting participants. A total of 50 individuals are needed to be recruited from 1 site in order for the study to move forward." - Anonymous Online Contributor